BEUDAMED
    FDA Registration Inactive 🇵🇰 Pakistan

    Byonyks X-1 APD Cycler

    · Expires 2025
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BYONYKS PVT LTD
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    45/A Khayaban-e-Iqbal, DHA 3 XX Block
    City
    Lahore Punjab
    Country
    PK

    Regulatory Submissions

    510(k) Number
    K243371

    Owner / Operator

    Firm Name
    Byonyks Pvt Ltd
    Operator Number
    10093647
    Address
    45/A Khayaban-e-Iqbal, DHA 3 XX Block
    City
    Lahore
    State
    Punjab
    Postal Code
    54000
    Country
    PK
    Correspondent
    Eric J Flachbart

    US Agent

    Business Name
    Byonyks Medical Devices Inc.
    Contact Name
    Eric Flachbart
    Address
    550 E Devon Ave Ste 140
    City
    Itasca
    State
    IL
    ZIP
    60143
    Country
    US
    Email
    [email protected]
    Phone
    813 9973230

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ

    Proprietary Names

    Byonyks X-1 APD Cycler Byonyks Automated PD Set DS-1

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)